ANDA 209750

APOTEX

FDA Drug Application

Application #209750

Application Sponsors

ANDA 209750

APOTEX

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

750MG/5ML

0

ATOVAQUONE

ATOVAQUONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-10-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-09-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-09-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

APOTEX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209750
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOVAQUONE","activeIngredients":"ATOVAQUONE","strength":"750MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/20\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/21\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-20
        )

)